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Precision public health (PPH) can maximize impact by targeting surveillance and interventions by temporal, spatial, and epidemiological characteristics. Although rapid diagnostic tests (RDTs) have enabled ubiquitous point-of-care testing in low-resource settings, their impact has been less than anticipated, owing in part to lack of features to streamline data capture and analysis.
We aimed to transform the RDT into a tool for PPH by defining information and data axioms and an information utilization index (IUI); identifying design features to maximize the IUI; and producing open guidelines (OGs) for modular RDT features that enable links with digital health tools to create an RDT-OG system.
We reviewed published papers and conducted a survey with experts or users of RDTs in the sectors of technology, manufacturing, and deployment to define features and axioms for information utilization. We developed an IUI, ranging from 0% to 100%, and calculated this index for 33 World Health Organization–prequalified RDTs. RDT-OG specifications were developed to maximize the IUI; the feasibility and specifications were assessed through developing malaria and COVID-19 RDTs based on OGs for use in Kenya and Indonesia.
The survey respondents (n=33) included 16 researchers, 7 technologists, 3 manufacturers, 2 doctors or nurses, and 5 other users. They were most concerned about the proper use of RDTs (30/33, 91%), their interpretation (28/33, 85%), and reliability (26/33, 79%), and were confident that smartphone-based RDT readers could address some reliability concerns (28/33, 85%), and that readers were more important for complex or multiplex RDTs (33/33, 100%). The IUI of prequalified RDTs ranged from 13% to 75% (median 33%). In contrast, the IUI for an RDT-OG prototype was 91%. The RDT open guideline system that was developed was shown to be feasible by (1) creating a reference RDT-OG prototype; (2) implementing its features and capabilities on a smartphone RDT reader, cloud information system, and Fast Healthcare Interoperability Resources; and (3) analyzing the potential public health impact of RDT-OG integration with laboratory, surveillance, and vital statistics systems.
Policy makers and manufacturers can define, adopt, and synergize with RDT-OGs and digital health initiatives. The RDT-OG approach could enable real-time diagnostic and epidemiological monitoring with adaptive interventions to facilitate control or elimination of current and emerging diseases through PPH.
Rapid diagnostic tests (RDTs), specifically immunochromatographic lateral flow assays, can provide accurate real-time point-of-care diagnoses in low-resource settings and have been an important tool in the global health arsenal. Advances in microfluidics have enabled the medical device community to design smaller RDTs—as small as half the area of a business card and the thickness of a watch—that can be used to diagnose more conditions and are low cost—less than US $1 per device [
Therefore, we aimed to define axioms to underpin steps to incorporate RDTs into a PPH approach, identify an initial set of features (RDT’s hardware and software features) that would be needed to implement these axioms, and select a final evidence-based set of features that could be used by health policy and program implementers in integrating RDTs as tools for frontline health care workers at the community and clinic levels [
There are 3 core challenges faced within the current RDT ecosystem, which impede application and widespread implementation for PPH.
The lack of uniformity in RDT hardware and software substantially limits the integration of public health data from RDTs into current health information systems, thereby impeding their ability to respond to emerging crises [
Current rapid diagnostic test processes (left) use undefined or proprietary standards, which lead to multiple incompatible protocols (ie, incompatible apps and devices). The rapid diagnostic test open guideline process (right) uses standard guidelines to produce modular reference rapid diagnostic tests that are compatible and can be read by a well-defined protocol for devices and apps. ID: identifier code or number for each device; ML: machine learning; POC: point-of-care; RDT: rapid diagnostic test.
One strategy to improve the uniformity, amount, and quality of information collected from RDTs is to use custom hardware readers and image capture and analysis devices (eg, the DekiReader [
Any diagnostics integrated with smartphones would still involve manual use of an RDT and interaction with patients. However, several studies have documented the challenges faced by health care workers in translating their competency to use one RDT to comparable competency with another (ie, those for similar diseases, from other manufacturers, or with revised procedures). The lack of consistency contributes to high error rates in RDT usage and interpretation and limits their impact [
Based on these challenges, we define 3 axioms that underpin solutions (
Rapid diagnostic test open guideline axioms.
Axiom | Description |
Axiom 1: Maximize rapid diagnostic test (RDT) data usage by capturing and structuring information for integration | To address the custom hardware challenge, we designed RDT open guidelines (OGs) in line with the existing realities of the rapid diagnostic test manufacturing world. Manufacturers focused on creating tests simple enough to be used in clinical, community, and household settings by minimally trained community health workers, and eventually clients themselves. This need for widespread use leads us to define RDT-OGs to satisfy and facilitate these needs. |
Axiom 2: Any solution must rely on only readily available local resources | This allows implementers of RDT-OGs to create solutions accessible by locally available technology and capability, including those that use pre-existing devices in target communities, such as low-cost smartphones [ |
Axiom 3: Diagnostic interfaces should remain uniform or compatible | This applies to RDT hardware, the software reading and interpreting RDTs, and the data schemas integrating with external systems. When using software-based RDT readers, following Axiom 3 leads us to link individual RDTs to uniform interactive guidance of users as they conduct a diagnostic test. |
We have chosen to address the current challenges in RDTs with open guidelines in order to focus directly on the systems and integration problems they face.
This changing technology landscape, combined with a lack of individual RDT identifiers, inconsistent test use protocols, and the appearance of fraudulent and counterfeit RDTs, led to a relative decrease in information use; however, as the RDT community began to effectively encode and aggregate information and improve the training of health care workers, information use increased. Currently, RDTs have reached a tipping point—there are multiple proprietary hardware and software solutions, and medical systems are facing “information overload” [
Below, we describe our methods, present survey results from experts in RDT technology, formally establish an information utilization index (IUI), and define how various RDT features gather information. We use this to assess World Health Organization (WHO)–prequalified RDTs in comparison to a prototype RDT based on open guidelines and then discuss these results and related work in field-based hardware and software diagnostics and standards. As access to telecommunications networks improves worldwide, and advanced information systems become more widely used by ministries of health and global health organizations, the community can dramatically accelerate the transformational impact promised by RDTs.
The trajectory of information use in response to rapid diagnostic test technology innovation, which shows the introduction of rapid diagnostic tests and their initial impact (black line) followed by subsequent challenges (red line) and improvements (green line). Potential future paths are also shown: a lower growth in information utilization under the current incremental improvements (gray dashed line) or an accelerating trajectory enabled with rapid diagnostic test open guidelines (blue dashed line). GTIN: global trade item number; RDT: rapid diagnostic test.
To identify key issues related to data capture and use from RDTs, we conducted a review of published papers using the Semantic Scholar artificial intelligence–enabled research search engine [
The literature review and PPH axioms were used to identify the fundamental features and feasibility of open guidelines for RDTs that maximize information usage for PPH. A survey was designed, which comprised 30 questions (
We note that the survey was exempt from human subjects research as per guidelines from the US Department of Health and Human Services as it assessed a public benefit or service and was not about humans, and did not collect sensitive information.
Survey results and the literature review were used to identify essential information features for RDTs and their integration into health care platforms to support PPH. The presence or absence of a feature for a specific RDT could be used to calculate an IUI defined as
The review of published literature and thematic extraction of concepts related to information capture and usage from RDTs led us to identify the following core areas that affect information usage (
Core areas that affect information usage.
Core areas | Description |
Challenges in using commonly deployed rapid diagnostic tests (RDTs). | This is related to issues of RDT choreography, and proper reading and interpretation even when control and results lines were clear. |
Existing barriers for mobile imaging of RDTs. | This referred to shadows from the cassette on the surface of the immunochromatographic strip, or glare from the cassette and surface of the strip, all of which hindered image capture quality. |
Criteria for designing RDT standards. | This included specific characteristics of RDTs that could be feasibly standardized. |
Barriers to RDT manufacturing standards. | This referred to cost and other factors that could hinder manufacturing to an enhanced standard. |
Feasibility and features for smartphone-read RDTs. | This included the practicality of using identified features in the clinical or field setting. |
Perceptions of non–human-readable RDTs (eg, electrochemical readouts). | This included whether or not read-out systems for RDTs would be acceptable for clinical or field personnel, if the actual reaction was not observable. |
We contacted 81 stakeholders, and 33 completed the questionnaire (16 researchers, 7 technologists, 3 manufacturers, 2 doctors or nurses, and 5 others). Respondents were most concerned about the proper use of RDTs (agreed: 30/33, 91%), their interpretation (agreed: 28/33, 85%), and reliability (agreed: 26/33, 79%). Respondents were confident that smartphone-based RDT readers could address some reliability concerns (agreed: 28/33, 85%) and that readers were more important for complex or multiplex RDTs (agreed: 33/33, 100%).
Based on these results, and because RDTs are embedded in a set of protocols and practices defined by health care workers, institutions, clients, and communities, proper usage of rapid diagnostic tests depends not only on a physical device but also on its integration into the larger ecosystem. In this context, to maximize information usage, an RDT platform must function effectively in all phases of its life cycle, with added value at each phase.
Specific stakeholder results are divided into discrete phases of the rapid diagnostic test life cycle (Manufacture, Shipping, Use, Interpretation, and Disposal), and RDT capabilities are divided into themes (Metadata, Molding of the Cassette, Printed Data, and Smartphone Reader) (
We identified 11 essential information features for RDTs and their integration into health care platforms, which define components of the IUI (
Conceptual framework of gaps in information use through the rapid diagnostic test life cycle. Information utilization (vertical axis) is quantified relative to 5 distinct phases of the rapid diagnostic test life cycle (horizontal axis): Manufacturing, Shipping, Use, Interpretation, and Disposal. Over the life cycle, the information utilization of the current process increases (black line), but with the use of rapid diagnostic test open guidelines, information utilization would increase (blue line) as a result of several features (list at bottom).
Smartphone or other device reader exists
Instructions included
Cassette is not reflective
Test strip is not reflective
Shadow does not exist on test window
Expiration date printed on device
Identifier printed on device
Color calibration panel on device
2D barcode on device
Test name clearly printed on device
Regulator (eg, World Health Organization) approved for lab and field use
The IUI—which provides an overview of how much information current diagnostics can capture and where there is room for improvement—for prequalified RDTs and an OG RDT had values ranging from 0 to 0.75 (mean 0.27; median 0.30, IQR 0.25) (
Information utilization index for WHO prequalified rapid diagnostic tests (RDTs). Scores were calculated for 33 WHO prequalified devices that had accessible information (blue, names listed below), as well as an RDT based on the RDT Open Guidelines (grey). The median information utilization score was 0.30 (magenta line), in contrast to 0.91, the score for an Open Guidelines RDT. 70% (top bracket) of the Open Guidelines RDT score can be attributed to non-physical changes, while the remaining 30% (bottom bracket) requires physical changes to the RDT.
Our RDT-OGs recommend the horizontal integration of RDT hardware through consistent physical modules, thereby enabling vertical integration of RDT software through consistent protocols linking supply chain, test choreography, and interpretation. In
In comparing the optimized IUI and design of the reference RDT-OGs to others, we observed both the heterogeneity and common structures across all RDTs. We have designed RDT-OGs to be useful whether adopting all recommendations, a subset of modules, or using existing cassettes linked to an RDT-OG–compatible software platform. Defining common data models and schemas provides an information architecture that would encapsulate data from any module combination that exists on the RDT. The RDT-OG data schema can be effectively encoded by the 2D barcode and easily drive the process forward via a reader app. The design and production aspects have proved feasible given the successful production of the prototype, and the field assessments, such as assessment of integration with epidemiological monitoring systems, are ongoing.
Creating a systematic way (
To the best of our knowledge, this is the first paper to propose guidelines to harmonize the hardware, software, and data standard used to read and interpret RDTs.
Unifying rapid diagnostic test functionalities based on formal guidelines. A rapid diagnostic test based on the rapid diagnostic test open guidelines (left) should have certain functional components, as indicated by the color-coded overlay. In contrast, 3 RDTs currently on the World Health Organization–prequalified list have only some of these components (right, with color-coded overlays).
In a system that incorporates rapid diagnostic test open guidelines, data are captured and digitized data from rapid diagnostic tests using a smartphone app that is compatible with the rapid diagnostic test open guidelines. These data are transmitted to a health information system platform and integrated with health system data, laboratory data, and other relevant data, then used to build machine learning models that both feed upstream, to smartphone apps to model symptoms and to be used to better interpret results, as well as downstream, for monitoring. Planners, managers, and researchers can use the real-time data to decide on modifications to existing programs and plan new programs. The color of the lines identifies the primary participant in that portion of the workflow, and the badges depict where to apply the features of the rapid diagnostic test open guideline. ML: machine learning; RDT: rapid diagnostic tests.
A Fast Healthcare Interoperability Resources–based workflow using the Device Definition resource for Open Guidelines based rapid diagnostic tests connected to Device, Observation, and Patient resources. Medical devices are defined using the DeviceDefinition resource (to specify their physical characteristics and links to external information systems). Each rapid diagnostic test used corresponds to a Device resource linked to the appropriate DeviceDefinition resource, as well as to Patient and Observation resources that store patient information and test results, respectively.
It is useful to review the RDT-OG system with related hardware, software, and standard-based approaches to field diagnostics, and to note limitations and next steps to integrate the RDT-OGs into the digital health ecosystem.
Hardware-based field diagnostics require reusable equipment to function and connect to software systems. For example, the DekiReader is a portable device that guides users through a malaria RDT, reads, and automatically interprets test results; it is notable that its results are not significantly different from human readings [
In contrast, software-based field diagnostics do not require additional hardware to function, while having accuracy comparable to human interpretations of RDTs or images of used tests [
Though these approaches integrate modern software, their generalizability is limited by having been designed in the absence of guidelines that standardize their solutions, and therefore do not adhere to PPH axioms 2 and 3. Vashist et al [
Yager et al [
There is a growing consensus that point-of-care diagnostics and smartphones equipped with digital health solutions are converging and that this advancement may significantly expand self-managed care [
Existing standards for diagnostics encompass RDTs, including several related standards in health technology, medical devices, and precision medicine. For example, given that most rapid diagnostic tests have maximal temperature limits for storage and use, temperature exposure monitors such as those used on vaccine vials would be warranted based on performance degradation from heat exposure [
Regulators, such as the US Food and Drug Administration, define pathways to classify novel medical devices, including communication-enabled RDTs, for which there are no similar existing devices [
This study has some limitations. First, the response rate from the survey was 40% (33/81), and the survey results may have benefited from additional feedback from a broader group. Nevertheless, there was strong thematic concordance between core responses from the survey and findings from the literature review. Second, after designing the open guidelines, we did not solicit additional feedback from the same and similar groups of persons who were contacted for the survey. This additional step would serve to validate the utility of the open guidelines. We note that our goal was to collect feedback from RDT producers and users of RDT-OGs. Third, we limited ourselves to information usage issues and solutions for cassette-based rapid tests and did not include the simpler dipstick type strips. However, the same concepts would apply and would need to be implemented in a way that is compatible with the lower space and cost profile of such tests [
In response to the goals and ambitions of the RDT community, we defined PPH axioms and derived RDT-OGs. The recommended modular foundation is designed to accelerate current RDT development, fieldwork, and successfully translate RDTs into effective field evaluations and deployments at scale. These guidelines thus confer functionality to diagnostic devices, the smartphone apps interpreting them, and the health information system analyzing them. For example, temperature sensors may be essential to assure proper storage and quality of some rapid diagnostic tests [
National and global policy makers have shown a willingness and ability to convene communities around guidelines that benefit RDT stakeholders; for example, the WHO prequalification of medicines program, FHIR, SNOMED, and LOINC. As the WHO, the Global Fund, Foundation for Innovative New Diagnostics, and others continue this work, there is ample opportunity to adopt formal guidelines around RDTs and their usage. For example, the WHO’s role in creating and promoting prequalified malaria RDTs has incentivized manufacturers to increase low-cost RDT production [
Thus, by providing guidance for RDT hardware, software, and data interoperability, standards-setting organizations can transform RDTs into a formidable public health tool for disease prevention and treatment, in addition to diagnosis. These innovations can accelerate long-term disease control efforts, such as for malaria, which is responsible for 7.8% of the annual deaths of children under 5 years old (20,000 children worldwide [
Survey instrument.
Fast Healthcare Interoperability Resources
information utilization index
open guideline
precision public health
rapid diagnostic test
World Health Organization
This research was supported by the Bill and Melinda Gates Foundation where Arunan Skandarajah provided helpful insights, discussion, and review of these ideas during his tenure. The technical and implementation teams at the Summit Institute for Development, the Kenya Medical Research Institute, and Ona assisted in the operationalization of this work, results of which will be published elsewhere; Craig Appl, Samuel Githengi, and Vincent Karuri provided insightful commentary on applying Fast Healthcare Interoperability Resources (FHIR) and software engineering techniques to this work. We thank Ted Prusik and Mohannad Abdo of Temptime Corp. and Zebra Technologies Corp. for helpful guidance and support.
None declared.